医療従事者の為の最新医療ニュースや様々な情報・ツールを提供する医療総合サイト

Astellas Pharma Inc. Is First Japanese Pharma Company to Join SAFE-BioPharma

2013年06月19日 PM09:10
このエントリーをはてなブックマークに追加


 

FT. LEE, N.J.

Astellas Pharma Inc. (www.astellas.com), a pharmaceutical company dedicated to improving the health of people around the world through innovative and reliable pharmaceutical products, has joined SAFE-BioPharma Association, the non-profit industry coalition responsible for the ongoing development and implementation of the global SAFE-BioPharma® digital identity and signature standard. As a member of the association, Astellas is able to utilize the SAFE-BioPharma standard throughout its operations. It is the first Japanese pharmaceutical company to become a SAFE-BioPharma member.

Digital identity credentials compliant with the SAFE-BioPharma standard are used to manage cyber-identities in the biopharmaceutical and healthcare sectors and to apply a higher form of electronic signature to electronic documents.

SAFE-BioPharma identity credentials will be used in several ways across the organization including application of digital signatures to submission documents for FDA and EU regulatory agencies and on a full range of clinical documents. Astellas also will use SAFE-BioPharma identity credentials for a variety of processes such as certifying scanned documents associated with case processing, computerized system validation for IT systems, and for change management procedures.

In addition to Astellas, SAFE-BioPharma pharmaceutical members include Abbott, AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline, Eli Lilly, Merck, Pfizer, Roche and Sanofi.

“We welcome Astellas to the expanding community of organizations using the SAFE-BioPharma standard. Their use of the standard will help improve productivity, cost reduction, and time to market by moving their processes more completely online,” said Mollie Shields-Uehling, president and CEO, SAFE-BioPharma Association.

In 2012, Astellas Pharma was a winner of the SAFE-BioPharma “Digi” Award in global expansion for its innovative use of SAFE-BioPharma digital signatures in a virtual clinical process pilot project in Japan.

The SAFE-BioPharma standard was created by the biopharmaceutical industry to provide standardized, high-assurance identity trust for cyber-transactions. The US CIO Council, the FDA and the EU EMA participate in the standard’s ongoing development. Among its rules and regulations, the standard requires a close bond between the user’s cyber-identity and actual identity. Digital signatures based on the standard are more secure and legally binding than conventional electronic signatures and are recognized by regulatory agencies throughout the U.S. and Europe.

The identity resides in a computer, token, or, increasingly, in a highly-secure hardware module in the cloud and, in addition to applying signatures, is used for authorized access to information stored behind company gateways, portals and firewalls.

More about SAFE-BioPharma at www.safe-biopharma.org.

More about Astellas at www.astellas.com.

SAFE-BioPharma® is a trademark of SAFE-BioPharma Association. Any use of this trademark requires approval from SAFE-BioPharma Association.

CONTACT

SAFE-BioPharma Association
Jon Weisberg, 801-359-9977
cell:
801-860-9977
Jon.weisberg@safe-biopharma.org

Related Posts Plugin for WordPress, Blogger...
 

同じカテゴリーの記事 

  • Daiichi Sankyo and Puma Biotechnology Announce Research Collaboration with Major Cancer Center in HER2-Mutated Cancer
  • 武田和Seattle Genetics呈报3期ECHELON-1临床试验的阳性数据,该试验评估ADCETRIS® (brentuximab vedotin)用于晚期霍奇金淋巴瘤的一线治疗
  • ADCセラピューティクスが当社の新規抗体薬物複合体ADCT-301の第I相中間データを発表
  • Intercell USA Changes Name to Valneva USA, Inc. and Expands Commercial Presence
  • ADC Therapeutics präsentiert Zwischenergebnisse aus Phase-I-Studie zu neuartigem Antikörper-Wirkstoff-Konjugat ADCT-402